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06.08.2020 GlobeNewswire: Idorsia Japan confirms daridorexant dose response in Japanese patients with insomnia – preparation for a local registration program advancing

Idorsia Japan confirms daridorexant dose response in Japanese patients with

insomnia – preparation for a local registration program advancing


Allschwil, Switzerland, and Tokyo, Japan – August 6, 2020



Idorsia Ltd (SIX: IDIA), Idorsia Pharmaceuticals Japan today announced the

positive conclusion of a dose-confirmation study for daridorexant, Idorsia’s

dual orexin receptor antagonist, in Japanese patients with insomnia. On the

basis of the positive results, preparation of registration studies in Japan is

now on-going.


The Phase 2 study was a multicenter, double-blind, randomized,

placebo-controlled, 4-period, 4-treatment crossover polysomnography dose

response study to investigate the efficacy and safety of daridorexant on the

first 2 days of each treatment period in Japanese patients with insomnia. In

addition, the 4 th double-blind treatment period was followed by a treatment

duration of 12 days to investigate subjective efficacy variables and safety



Treatment with daridorexant in 47 adult patients (ranging from 16 to 64 years)

showed a significant dose-dependent decrease in WASO at Day 1 & 2 (average

decrease of wake time after sleep onset from baseline on the 2 nights of

treatment, measured by polysomnography). In addition, daridorexant

significantly decreased LPS (latency to persistent sleep) in a dose-dependent

manner. Furthermore, daridorexant showed significant improvements on subjective

sleep parameters such as sWASO (subjective wake after sleep onset), sLSO

(subjective latency to sleep onset) and sTST (subjective total sleep time).

Treatment with daridorexant was generally well tolerated. Most of the adverse

events were mild. There were no reports of serious adverse events and

withdrawals related to daridorexant.


Jean-Paul Clozel, MD and Chief Executive Officer of Idorsia, commented:

“Our Japanese team, under the leadership of Dr Satoshi Tanaka, has done an

outstanding job to advance the development of daridorexant for Japanese

patients so rapidly. The results we see in this Phase 2 dose-confirmation

study, extend the excellent profile of daridorexant seen in two large pivotal

global studies to a Japanese population. This will enable initiation of the

registration study in Japan so that Japanese patients can benefit from

daridorexant as soon as possible.”


Dr Satoshi Tanaka, President of Idorsia Pharmaceuticals Japan, commented:

“It is very satisfying to see the results of the first randomized trial run by

the Idorsia team in Japan. The team has delivered robust, high-quality data

which clearly support the development of daridorexant for Japanese patients

with insomnia. We are now working very hard with our partner Mochida to prepare

for the Phase 3 registration studies in Japan.”


In April and July 2020, Idorsia reported positive results in each of the two

pivotal Phase 3 studies of daridorexant in patients with insomnia. The program

demonstrated efficacy of treatment with daridorexant on objective and

subjective sleep parameters, and daytime functioning, with patients reporting

no morning sleepiness, and no evidence of rebound or withdrawal symptoms upon

treatment discontinuation. More details and commentary can be found in the

dedicated press releases ( first study ), ( second study ) and the investor

webcasts ( first study ), ( second study ) which are available for replay on

the corporate website.

In December 2019, Idorsia and Mochida Pharmaceutical Co., Ltd. entered into an

exclusive license agreement for the supply, co-development and co-marketing of

daridorexant for insomnia and related disorders in Japan.


Notes to the editor


About insomnia

Insomnia is a condition of overactive wake signaling that can have a profound

effect on the lives of patients. Insomnia can be defined as difficulty falling

asleep and / or staying asleep, occuring at least three times a week for a

minimum of three months.


It is estimated that as many as one in ten people suffer from insomnia and its

impact is often underestimated. In reality, it can be a distressing condition

that can impair quality of life. Sleepless nights can leave people feeling

irritable and out of sorts – this may affect many aspects of daily life, from

studying and employment to social activities and relationships. People who

suffer from insomnia may lack the energy or motivation to exercise or to take

part in social activities. It can also have a significant economic impact as it

increases the risk of accident and injury on the road or in the workplace, and

is a leading cause of absenteeism and reduced productivity at work. People with

insomnia are more likely to experience feeling down or depressed, lack

concentration, and suffer from poor energy levels during the day compared with

people who sleep well. In addition, worrying about sleep can cause stress and

may lead to negative thought patterns which may in turn make it more difficult

to sleep, setting up a vicious circle. Chronic insomnia is associated with

cardiovascular and cerebrovascular diseases, and increased mortality.


The goal of treatments for insomnia is to improve sleep quality and quantity,

as well as reducing insomnia-related impaired daytime functioning, while

avoiding adverse events and next morning residual effect. Current treatment of

insomnia includes cognitive behavioral therapy, sleep hygiene recommendations,

and pharmacotherapy. The most widely prescribed products on the market that are

indicated for insomnia enhance the effects of gamma-aminobutyric acid (GABA),

the major inhibitory neurotransmitter in the central nervous system. Such

medications are only approved for short-term use and are associated with side

effects such as next-morning residual effects, anterograde amnesia, and risk of

tolerance and dependence.


About the orexin system

Wake and sleep signaling is regulated by intricate neural circuitry in the

brain. One key component of this process is the orexin system, which helps

promote and consolidate wakefulness. There are two forms of orexin

neuropeptides – Orexin A and Orexin B. Orexin promotes wakefulness through its

receptors OX 1 R and OX 2 R. In combination, these neuropeptides and receptors

comprise the orexin system. The orexin system stimulates target neurons in the

wake system – leading to the release of several chemicals (Dopamine, Serotonin,

Histamine, Acetylcholine, Norepinephrine) which promote wakefulness. Under

normal circumstances, orexin levels rise throughout the day as wakefulness is

promoted and then consolidated and fall at night. Overactivity of the orexin

system is thought to be an important driver of insomnia.


Idorsia’s research team has been working on the science of orexin and orexin

receptors since they were first described in 1998. The teams initial work led

to the conclusion that antagonism of the orexin system was the key to

preserving a natural sleep architecture for patients with insomnia. With this

as the target the team started to design a dual antagonist with a rapid effect,

and a duration of action sufficient for the night but short enough to avoid any

negative residual activity the following morning at optimally effective doses.


About dual orexin receptor antagonism

Dual orexin receptor antagonists – or DORAs – are an entirely di­fferent

approach to treating insomnia than previous drug classes, turning down

overactive wakefulness by blocking the activity of orexin. DORAs specifically

target the orexin system by competitively binding with both receptors and

thereby reversibly blocking the activity of orexin. It is hypothesized that

blocking orexin receptors reduces the downstream activity of the other wake

promoting neurotransmitters that are overactive in insomnia, leading to the

clinical efficacy demonstrated by orexin receptor antagonists.


References Dauvilliers, Y., et al. (2020). Ann Neurol 87(3): 347-356. Zammit,

G., et al. (2020). Neurology 94(21): e2222-e2232. Muehlan, C., et al. (2020). J

Clin Psychopharmacol 40(2): 157-166. Muehlan, C., et al. (2020). J

Psychopharmacol 34(3): 326-335. Boof, M. L., et al. (2019). Eur J Clin

Pharmacol 75(2): 195-205. Muehlan, C., et al. (2019). Curr Drug Metab 20(4):

254-265. Muehlan, C., et al. (2019). Eur Neuropsychopharmacol 29(7): 847-857.

Muehlan, C., et al. (2018). Clin Pharmacol Ther 104(5): 1022-1029. Treiber, A.,

et al. (2017). J Pharmacol Exp Ther 362(3): 489-503.


About Mochida

Mochida Pharmaceutical Co., Ltd. has been committed to research and

development of innovative pharmaceutical products since its establishment

thereby providing distinctive medicines to the medical field. Currently, the

core pharmaceutical business focuses resources on the targeted areas of

cardiovascular medicine, obstetrics and gynecology, dermatology, psychiatry and

gastroenterology, while also providing medicine for intractable disease as well

as generics including biosimilars, to meet medical needs. For more information

on Mochida Pharmaceutical Co., Ltd., please see


About Idorsia

Idorsia Ltd is reaching out for more - We have more ideas, we see more

opportunities and we want to help more patients. In order to achieve this, we

will develop Idorsia into one of Europe’s leading biopharmaceutical companies,

with a strong scientific core.


Headquartered in Switzerland - a biotech-hub of Europe - Idorsia is

specialized in the discovery and development of small molecules, to transform

the horizon of therapeutic options. Idorsia has a broad portfolio of innovative

drugs in the pipeline, an experienced team, a fully-functional research center,

and a strong balance sheet – the ideal constellation to bringing R&D efforts to

business success.


Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June

2017 and has over 800 highly qualified specialists dedicated to realizing our

ambitious targets.


Idorsia Pharmaceuticals Japan was established, under the leadership of Dr

Satoshi Tanaka, in 2018 to conduct clinical development and prepare the

commercialization of Idorsia's innovative and promising compounds for patients

in Japan.


For further information, please contact

Andrew C. Weiss

Senior Vice President, Head of Investor Relations & Corporate Communications

Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil

+41 58 844 10 10


The above information contains certain 'forward-looking statements', relating

to the company's business, which can be identified by the use of

forward-looking terminology such as 'estimates', 'believes', 'expects', 'may',

'are expected to', 'will', 'will continue', 'should', 'would be', 'seeks',

'pending' or 'anticipates' or similar expressions, or by discussions of

strategy, plans or intentions. Such statements include descriptions of the

company's investment and research and development programs and anticipated

expenditures in connection therewith, descriptions of new products expected to

be introduced by the company and anticipated customer demand for such products

and products in the company's existing portfolio. Such statements reflect the

current views of the company with respect to future events and are subject to

certain risks, uncertainties and assumptions. Many factors could cause the

actual results, performance or achievements of the company to be materially

different from any future results, performances or achievements that may be

expressed or implied by such forward-looking statements. Should one or more of

these risks or uncertainties materialize, or should underlying assumptions

prove incorrect, actual results may vary materially from those described herein

as anticipated, believed, estimated or expected.




Anhang Medienmitteilung PDF



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